Your session is about to expire
← Back to Search
Hormone Therapy
LUM-201 for Growth Hormone Deficiency (OraGrowtH211 Trial)
Phase 2
Waitlist Available
Research Sponsored by Lumos Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to month 36
Awards & highlights
Summary
This trial looks at the safety and effectiveness of a drug to help kids with growth hormone deficiency.
Who is the study for?
This trial is for children with Idiopathic Pediatric Growth Hormone Deficiency who have already been part of a previous LUM-201 study. They must have completed at least 12 months in that study and be cleared to continue treatment. Children with conditions that add risk or those on certain long-term medications affecting LUM-201 metabolism cannot participate.
What is being tested?
The trial is testing the long-term safety of a drug called LUM-201 in children with growth hormone deficiency. It will also look at how the body responds to the drug over time and its effectiveness in promoting growth.
What are the potential side effects?
While specific side effects are not listed, they may include reactions related to growth hormone treatments such as joint pain, headaches, muscle pain, and issues with insulin resistance. Long-term safety monitoring aims to identify any additional side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to month 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to month 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events
Secondary study objectives
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
Change in Bone Age (BA)
Change in Weight SDS
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LUM-201 (1.6 mg/kg/day)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Lumos PharmaLead Sponsor
4 Previous Clinical Trials
122 Total Patients Enrolled
3 Trials studying Human Growth Hormone Deficiency
122 Patients Enrolled for Human Growth Hormone Deficiency
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term medication that affects how my body processes certain drugs.You were part of a previous study for pediatric LUM-201 GHD treatment and completed at least the 12-month visit. If you meet all other requirements, you may be able to continue the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: LUM-201 (1.6 mg/kg/day)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger